|Publication number||US7918350 B2|
|Application number||US 12/399,545|
|Publication date||5 Apr 2011|
|Filing date||6 Mar 2009|
|Priority date||24 Oct 2002|
|Also published as||CA2547905A1, CA2547905C, EP1706209A1, EP1706209B1, US7297272, US20040195190, US20080087601, US20080087614, US20090218277, WO2005065834A1|
|Publication number||12399545, 399545, US 7918350 B2, US 7918350B2, US-B2-7918350, US7918350 B2, US7918350B2|
|Inventors||Kyungyoon Min, Richard I. Brown, Alp Akonur, Julie Moriarty|
|Original Assignee||Fenwal, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (194), Non-Patent Citations (3), Classifications (26), Legal Events (2)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application is a continuation of application Ser. No. 11/927,033, filed on Oct. 29, 2007 now abandoned, which is a continuation of application Ser. No. 10/827,603, filed on Apr. 19, 2004, now U.S. Pat. No. 7,297,272, which is a continuation-in-part of application Ser. No. 10/279,765 filed Oct. 24, 2002, now U.S. Pat. No. 6,849,039 and entitled “Blood Processing Systems and Methods for Collecting Plasma Free or Essentially Free of Cellular Blood Components,” and claims the benefit of U.S. Provisional Application Ser. No. 60/533,820, filed Dec. 31, 2003, which applications are incorporated by reference herein.
The present invention relates in general to apparatus and methods for separating biological fluids, such as blood or blood components or other fluids, into one or more components.
The separation of biological fluid such as whole blood and blood components into its constituent components for various applications is well known. Many commercially available separation systems are based on principles of centrifugation, which separates the fluid components according to density. Various devices and systems are known that employ centrifugal separation of blood or blood components including the CS-3000®, Amicus®, ALYX®, separators marketed by Baxter Healthcare Corporation of Deerfield, Ill., the Spectura®, and Trima® separators by Gambro BCT of Lakewood, Colo., the AS104 from Fresenius Homecare of Redmond, Wash., and the V-50 and other models from Haemonetics Corporation of Braintree, Mass. Various centrifuge devices are also disclosed in U.S. Pat. No. 6,325,775, Published PCT Application Nos. PCT/US02/31317; PCT/US02/31319; PCT/US03/33311 and PCT/US03/07944, and U.S. Published Patent Applications 20020094927 and 20020077241. Each of these patent and patent applications are hereby incorporated by reference herein.
Although centrifugal blood separator devices are thus well known, efforts continue to develop devices that are smaller, lighter, more portable, versatile and/or efficient in the separation and collection of one or more different components of blood or other biological fluids.
The present invention includes apparatus and methods for separation of a biological fluid, such as whole blood, and optional collection of at least one of the fluid components.
In accordance with one embodiment of the present invention, a separation channel is provided for rotation about an axis. The separation channel includes radially spaced apart inner and outer side wall portions and an end wall portion. The channel has an axial length relative to the axis. An inlet is provided to convey fluid into the channel and a barrier is located in the channel intermediate of the inner and outer side wall portions. The barrier includes both upstream and downstream sides and includes a first flow path which communicates between the upstream and downstream sides. The separation channel further includes a collection region which is located downstream of the barrier and in fluid communication with the first flow path. The collection region is defined at least in part by an end wall portion which is axially spaced from the end wall portion of the channel. Additionally, first and second openings communicate with the collection region so as to allow flow of one or more fluid components, such as blood components, from the collection region.
In another embodiment of the invention, a section of an outer side wall portion of the channel is located in the vicinity of a barrier and is positioned radially outward of the outer side wall portion that is upstream of such section.
In a further embodiment of the separation channel, a barrier extends to an outer side wall portion and joins the outer side wall portion along a substantial portion of the axial length of the channel. A first flow path allows fluid communication between the upstream and downstream sides of the barrier.
In yet a further embodiment of the separation channel, a barrier may extend to a radial position which is inward of the radial location of an inner side wall portion.
An additional embodiment of the separation channel includes a first flow path which communicates between the upstream and downstream sides of a barrier and further includes first and second exit flow paths. The first exit flow path communicates with the channel upstream of the barrier while a second exit flow path communicates with the channel downstream of the barrier. The first and second flow paths join at a location radially inward of an inner wall portion of the channel.
In addition, another separation channel may provide that a plurality of exit openings from the channel are located downstream of a barrier. In this respect, the channel is free of an exit opening upstream of the barrier inasmuch as fluid components are not allowed to exit the channel at a location which is upstream of the barrier. A first fluid flow path allows communication between the upstream and downstream sides of the barrier but does not provide an exit flow path to outside of the channel.
In a still further embodiment of the separation channel, a barrier wall extends to a radially outer side wall portion of the channel. A first flow path communicates between the upstream and downstream sides of the barrier and is spaced from one of the opposed end wall portions of the channel. The separation channel further includes a second flow path which communicates between the upstream and downstream sides of the barrier, which second flow path is defined by a surface of the other end wall portion.
Although described later in terms of certain preferred embodiments, it should be understood that the separation channels of the present invention are not limited to the identical structures shown. For example, a separation channel may comprise a reusable platen, bowl or rotor into which a disposable flexible, rigid or semi-rigid liner is placed so that blood flows through the liner and does not contact the reusable portion. In such case, the configuration of the channel platen, bowl or rotor defines the shape of fluid flow path and the disposable liner assumes a corresponding shape during operation. Examples of such may be seen in the CS-3000®, Amicus® and Spectra® centrifugal separation systems. Alternatively, the separation channel may be entirely disposable. For example, the channel may be formed of rigid plastic having a pre-formed shape through which the blood or other biological fluid is processed. Of course, the channel could be entirely reusable, in which case it would need to be cleaned and possibly sterilized between uses—an inconvenient and time consuming procedure. It should be understood that the separation channel and methods described and claimed are intended to have a broad interpretation that includes all of the more specific structures, such as those mentioned above, in which it may find commercial application.
The separation channels or chambers described herein may be used for a variety of biological fluid separation and collection procedures. By way of example and not limitation, one of such separation methods comprises the steps of introducing a first fluid, such as whole blood, which comprises at least first and second components, e.g., blood components, having generally different density into a centrifugal field and allowing an interface to form between at least portions of the first and second components. The method includes removing a second fluid from one side of the interface and a third fluid from the other side of the interface, combining at least a portion of the second fluid with the first or third fluid and reintroducing the combined fluids into the centrifugal field, and removing at least one of the second or third fluid from the centrifugal field.
When the above method is applied to whole blood (first fluid), the second fluid may substantially comprise plasma and the third fluid may substantially comprise red cells. The combined second and first or third fluid may have a hematocrit which is approximately between 20 and 40 percent. The portion of the plasma which is removed from one side of the interface may include substantial numbers of platelets.
In accordance with another method of the present invention, the method includes introducing a first fluid, such as whole blood, which comprises first and second components having generally different density into a centrifugal field; allowing an interface to form between at least portions of the first and second fluid components; decreasing the force of the centrifugal field (such as by reducing the rotational field of separation chamber containing the fluid); and removing the first fluid component from the centrifugal field after the force of the centrifugal field is decreased.
Some or all of the above steps of this method may be repeated to enhance efficiency. For example, the step of removing the fluid component may be repeated so as to provide several collection cycles. The above method may have particular application in the collection of platelets from whole blood wherein the first fluid component comprises plasma which includes platelets.
A further method of the present invention provides for forming and reforming of the interface between the fluid components of different density. This method includes the steps of introducing a first fluid, such as whole blood which has at least first and second components of generally different density; allowing an interface to form between at least portions of the first and second components, such as between plasma and red cells of whole blood; sequentially and repeatedly removing fluid from the centrifugal field from one side of the interface and allowing the interface to reform.
When the method is applied to whole blood, the fluid which is removed from the centrifugal field comprises plasma and platelets. In particular, the fluid may comprise plasma which is rich in platelet concentration. The method may be performed so that the step of removing the fluid from one side of the interface is repeated at least two times.
The method may further include moving the interface radially inward so that the interface itself is in proximity with an aperture or opening, through which the plasma or platelets are removed. Where the step of removing is performed at least twice, it is contemplated that the interface may be returned to its initial location prior to moving it to proximity with the aperture.
An additional method of the present invention includes a method for processing whole blood, which may serve to reduce the amount of time that the donor or other human subject or blood source is connected to the blood separation device. The method includes connecting a blood source to a separation device; introducing blood into a centrifugal field created by the device; and allowing an interface to develop between at least two blood components. The method further includes: removing a first blood component from the centrifugal field from one side of the interface; removing a second blood component from the centrifugal field from the other side of the interface; storing at least one of the first and second blood components; returning, at least in part, the other of the first and second blood components to the blood source; and withdrawing additional blood from the blood source. After the additional blood has been drawn, the blood source is disconnected, and the steps of introducing the blood into the centrifugal field and removing the first and second blood components are repeated. The first and second blood components that have been removed from the centrifugal field may be stored for later use as desired.
The system 10 includes two principal components. These are: (i) a blood processing device 14—shown in
A. The Processing Device
The blood processing device 14 is intended to be a durable item capable of long term use. In the illustrated and preferred embodiment, the blood processing device 14 is mounted inside a portable housing or case 36. The case 36 presents a compact footprint, suited for set up and operation upon a table top or other relatively small surface. The case 36 is also intended to be transported easily to a collection site.
The case 36 includes a base 38 and a hinged lid 40, which closes for transport (as
A controller 16 is carried onboard the device 14. The controller 16 governs the interaction between the components of the device 14 and the components of the flow set 12 to perform a blood processing and collection procedure selected by the operator. In the illustrated embodiment, the controller 16 comprises a main processing unit (MPU), which can comprise, e.g., a Pentium® type microprocessor made by Intel Corporation, although other types of conventional microprocessors can be used. The MPU can be mounted inside the lid 40 of the case 36. A power supply with power cord 184 supplies electrical power to the MPU and other components of the device 14.
Preferably, the controller 16 also includes an interactive user interface 42, which allows the operator to view and comprehend information regarding the operation of the system 10. In the illustrated embodiment, the interface 42 is implemented on an interface screen carried in the lid 40, which displays information for viewing by the operator in alpha-numeric format and as graphical images.
Further details of the controller 16 can be found in Nayak et al, U.S. Pat. No. 6,261,065, which is incorporated herein by reference. Further details of the interface can be found in Lyle et al, U.S. Pat. No. 5,581,687, which is also incorporated herein by reference.
B. The Flow Set
The flow set 12, is intended to be sterile, single use, disposable item. Before beginning a given blood processing and collection procedure, the operator loads various components of the flow set 12 in association with the device 145 (as
The flow set includes a blood processing chamber 18, a fluid actuated pump and valve cassette 28, and an array associated processing containers 64 and flow tubing coupled to the chamber 18 and the cassette 28. Several embodiments of the chamber 18 will be identified in greater detail below.
1. The Blood Processing Chamber
In the illustrated embodiment (see
The centrifuge station 20 rotates the processing chamber 18. When rotated, the processing chamber 18 centrifugally separates a fluid, preferably whole blood which is received from a donor into component parts, principally, red blood cells, plasma, and intermediate layer called the buffy coat, which is populated by platelets and leukocytes. As will be described later, the configuration of the chamber 18 can vary according to the intended blood separation objectives. Several embodiments of the chamber 18 will be described below.
2. The Fluid Pressure-Actuated Cassette
In the illustrated embodiment, the set 12 also includes a fluid pressure-actuated cassette 28 (see
3. Blood Processing Containers and Tubing
Referred back to
An umbilicus 100 forms a part of the flow set 16. When installed, the umbilicus 100 links the rotating processing chamber 18 with the cassette 28 without need for rotating seals. The umbilicus 100 can be made from rotational-stress-resistant plastic materials, such as Hytrel® copolyester elastomers (DuPont).
Referring now to
The optical sensing station 46 optically monitors the presence or absence of targeted blood components (e.g., red blood cells and platelets) in blood conveyed by the tubes 104 and 106. The sensing station 46 provides outputs reflecting the presence or absence of such blood components. This output is conveyed to the controller 16. The controller 16 processes the output and generates signals to control processing events based, in part, upon the optically sensed events. Further details of the operation of the controller to control processing events based upon optical sensing have been described in one or more of the above-identified patent or applications, which have been incorporated herein by reference.
As shown (see
As also shown in
The device further includes one or more weigh stations 62 and other forms of support for containers. The arrangement of these components on the device 14 can, or course, vary depending on the processing objectives. By way of example and not limitation,
C. The Centrifuge Station
The centrifuge station 20 (see
As illustrated in
A carrier or rotor plate 84 spins within the yoke 70 about its own bearing element 86, which is attached to the top wall 74 of the yoke 70. The rotor plate 84 spins about an axis that is generally aligned with the axis of rotation 82 of the yoke 70.
Umbilicus drive or support members 92 and 94 and channels 96 and 98 (see
D. Interface Control by Optical Sensing
In any of the above-described blood processing procedures, the centrifugal forces present within the processing chamber 18 separate whole blood into a region of packed red blood cells and a region of plasma (as diagrammatically shown in
An intermediate region forms an interface between the red blood cell region and the plasma region. Intermediate density cellular blood species like platelets and leukocytes populate the interface, arranged according to density, with the platelets closer to the plasma layer than the leukocytes. The interface is also called the “buffy coat,” because of its cloud color, compared to the straw color of the plasma region and the red color of the red blood cell region.
It may be desirable to monitor the location of the buffy coat, either to keep the buffy coat materials out the plasma or out of the red blood cells, depending on the procedure, or to collect the cellular contents of the buffy coat. For that purpose, the system includes the optical sensing station 46, which houses two optical sensing assemblies is, also diagrammatically shown in
The first sensing assembly 146 in the station 46 optically monitors the passage of blood components through the plasma collection tube 106. The second sensing assembly 148 in the station 46 optically monitors the passage of blood components through the red blood cell collection tube 104.
The tubes 104 and 106 are made from plastic (e.g. polyvinylchloride) material that is transparent to the optical energy used for sensing, at least in the region where the tubes 104 and 106 are to be placed into association with the sensing station 46. The fixture 108 holds the tubes 104 and 106 in viewing alignment with is respective sensing assembly 148 and 146. The fixture 108 also holds the tube 102, which conveys whole blood into the centrifuge station 20, even though no associated sensor is provided. The fixture 108 serves to gather and hold all tubes 102, 104, and 106 that are coupled to the umbilicus 100 in a compact and easily handled bundle.
The first sensing assembly 146 is capable of detecting the presence of optically targeted cellular species or components in the plasma collection tube 106. The components that are optically targeted for detection vary depending upon the procedure.
The presence of platelets in the plasma, as detected by the first sensing assembly 146, indicates that the interface is close enough to the low-G wall of the processing chamber to allow all or some of these components to be swept into the plasma collection line (see
The second sensing assembly 148 is capable of detecting the hematocrit of the red blood cells in the red blood cell collection tube 104. The decrease of red blood hematocrit below a set minimum level during processing indicates that the interface is close enough to the high-G wall of the processing chamber to allow all or some of the components in the interface and perhaps plasma on the other side of the interface to enter the red blood cell collection tube 104 (see
Several embodiments of the chamber are described herein. These chambers may be used with the flow set 12 in association with the device 14 and controller 16 to conduct various collection procedures.
A. First Embodiment of the Blood Processing Chamber
The inside annular wall 206 is open between one pair of stiffening walls which form an open interior region 222 in the hub 204. Blood and fluids are introduced from the umbilicus 100 into and out of the separation channel 210 through this region 222. A molded interior wall 224 formed inside the region 222 extends entirely across the channel 210, joining the outside annular wall 208. The wall 224 forms a terminus in the separation channel 210, which interrupts flow circumferentially along the channel 210 during separation.
Additional molded interior walls divide the region 222 into three passages 226, 228, and 230. The passages 226, 228, and 230 extend from the hub 204 and communicate with the channel 210 on opposite sides of the terminus wall 224. Blood and other fluids are directed from the hub 204 into and out of the channel 210 through these passages 226, 228, and 230.
As the processing chamber 198 shown in
The whole blood separates as a result of centrifugal forces in the manner shown in
Because the red blood cell exit channel 246 extends outside the high-g wall 208, being spaced further from the rotational axis than the high-g wall, the red blood cell exit channel 246 allows the positioning of the interface between the red blood cells and the buffy coat very close to the high-g wall 208 during blood processing, without spilling the buffy coat into the red blood cell collection passage 230 (creating an spill under condition). The recessed exit channel 246 thereby permits red blood cells yields to be maximized (in a red blood cell collection procedure) or an essentially platelet-free plasma to be collected (in a plasma collection procedure).
B. Second Embodiment of the Blood Processing Chamber
As previously described with respect to embodiment of a chamber shown in
In the chamber 200 shown in
In the embodiment shown in
Additional molded interior walls divide the region 222 into three passages 226, 228 and 230. The passages 226, 228 and 230 extend from the hub 204 and communicate with the channel 210 opposite sides of the terminus wall 224. Blood and other fluids are directed from the hub 204 into and out of the channel 210 through these passages 226, 228 and 230.
As the processing chamber 200 is rotated (arrow R in
The whole blood separates within the chamber 200 as a result of centrifugal forces in the manner showing in
Circumferentially spaced adjacent the terminus wall 224 nearly 360-degrees from the whole blood inlet passage 226 are the plasma collection passage 228 and the red blood cell collection passage 230. In an upstream flow direction from these collection passages 228 and 230, a barrier 232 projects into the channel 210 from the high-G wall 208. The barrier 232 forms a constriction in the separation channel 210 along the inner side wall portion or low-G wall 206. In the circumferential flow direction of the blood, the constriction leads to the plasma collection passage 228.
A ledge 238 extends an axial distance within the opening 236 radially from the low-G wall 206. The ledge 238 constricts the radial dimension of the opening 236 along the radially outer or high-G wall 208. Due to the ledge 238, only red blood cells and other higher density components adjacent to the high-G wall 208 communicate with the opening 236. The ledge 238 keeps plasma, which is not adjacent the high-G wall 208, away from communication with the opening 236. Due to the radial restricted opening 236 along the high-G wall 208, the plasma has nowhere to flow except toward the plasma collection passage 228. The plasma exiting the separation channel 210 is thereby free or essentially free of the higher density materials, which exit the separation channel 210 through the restricted high-G opening 236.
The ledge 238 joins an axial surface 240, which is generally aligned with the low-G wall 206. The axial surface 240 extends axially along the axis of rotation to the red blood cell collection passage 230. By virtue of the barrier 232, the ledge 238, and other interior walls, the red blood cell collection passage 230 is isolated from the plasma collection passage 228 (as
C. Third Embodiment of the Blood Processing Chamber
The chamber 300 includes a separately molded base component 301 having a hub 304 that is disposed along an axis A of the chamber. The base 301 of the chamber 300 includes radially spaced inner (low-g) and outer (high-g) side wall portions 306 and 308, respectively. The side walls are consistently referred to in this description as the radially inner (or low-g) wall and the radially outer (or high-g) wall. The inner and outer side wall portions 306 and 308 and opposed end wall portions 302 and 314 generally define a circumferential (which is not limited to circular) blood separation channel 310. A first end wall portion 314 forms one axial boundary or bottom to the channel 310 and a second end wall portion or lid 302 (partially shown in
Although the inner and outer wall portions 306 and 308 are shown as substantially circumferential, i.e., as generally vertical walls having a generally uniform radius relative to a common axis A, other orientations, shapes, axes and radii are also possible. Also, while the top and bottom end wall portions are shown to be generally planar, it is also possible that these end wall portions could have other shapes such as curved, arcuate and the like. The shape and orientation of the channel also may depend on whether the channel is formed of flexible, semi-rigid, or rigid structures. It should also be appreciated that the designation of the end wall portions as “top” or “bottom” are not meant to limit these structures. Such terms are meant to be arbitrary and are merely used to distinguish one end wall from the other end wall in the relationship shown in the drawings in order to facilitate understanding of these structures.
As shown in
At the downstream end of the channel 310, first, second and third exit flow paths 328, 330 and 332 may define outlet paths for one or more fluid components from the channel 310. A dam or barrier 336 is also located at the downstream end of the channel 310 and will be described in further detail below.
When the channel 310 is operating under normal conditions—i.e., not under spill or over spill conditions—fluid in the first flow path 328 preferably flows either radially inward of the junction 352 (and outside of the chamber 300) or, alternatively, travels radial outward at the junction 352 into the second exit flow path 330. By “normal conditions”, it is meant that the blood components in the channel 310 are separated into plasma, buffy coat and red blood cells and are preferably disposed in the relative radial locations, as shown in
Under normal conditions, the direction of the fluid flow (e.g. plasma flow) in the second exit flow path 330 is generally such that fluid flows radial inward of the junction 352 towards the opening 331. The extent of the radial path traversed by the plasma in the second exit flow path 330 will depend on the radial location of the interface between the plasma and red blood cells. Preferably, plasma flows into the second exit flow path 330 from the first exit flow path 328 to fill the second exit flow path 330 radially inward of the interface but does not flow radially outward of the interface. Under normal conditions, the plasma from the first exit flow path 328 will predominantly flow out of the chamber 300 with some plasma flowing into the second exit flow path 330 to fill the area radially inward of the interface.
Although the preferred flow pattern of the first and second exit flow paths 328 and 330 is discussed above, it is also possible that the fluid within the first and second exit flow paths may follow a different flow pattern. This flow pattern may depend on the position of the interface associated with one or more fluid components and the rate at which one or more fluid components are collected from the channel 310 as well as other factors. By way of example, and not limitation, if the interface between the plasma and red blood cells is moved radially inward to force an over spill condition, then the fluid in the second exit flow path 330 may flow radially outward through the opening 329 at the junction 352.
As shown in
As shown in
As best seen in
During use, a fluid, such as whole blood, enters the inlet 326 and flows into the channel 310. As the fluid first enters the channel 310, the fluid is generally located at the top of the channel 310. The axial extent of fluid flow at the opening 325 of the inlet passageway 326 may be initially confined at its lower axial extent at the inlet by a bottom floor 354 (as seen in
In the channel 310, the fluid may essentially follow a spiral pattern (shown in broken lines in
As the blood flows downstream, centrifugal force allows the components of the blood to separate radially according to density within the channel 310. Further details of this separation are set forth in Brown, “The Physics of Continuous Flow Centrifugal Sell Separation,” Artificial Organ, 13(1):4-20 (1989).
Upstream of the barrier 336, at least one fluid component may be collected through the first exit flow path 328. Such component may include platelet poor plasma PPP or platelet rich plasma PRP. Such component also may flow into the second exit flow path 330 at the junction 352. Another fluid component, preferably, red blood cells, may flow into the first flow path 344 for removal through the third exit flow path 332. If the platelets are primarily located in the buffy coat, at least a substantial portion of the buffy coat is sequestered at the upstream side 338 of the barrier 336. In this regard, the barrier 336 may allow accumulation of platelets upstream of the barrier 336 at a certain point during the procedure, for example, where platelet poor plasma PPP is being removed from the channel 310. Such procedures will be discussed in further detail below. Thus, the portion of the interface between the plasma and red blood cells downstream of the barrier 336 preferably contains substantially less or virtually no platelets as compared to the interface located between these components upstream of the barrier 336.
Downstream of the barrier 336, the interface is allowed to form between the red blood cells and plasma which may also be either platelet rich or platelet poor plasma. Under normal conditions, the interface between the plasma and red blood cells is located at an intermediate radial location—i.e. between the inner and outer wall portions 306 and 308—. Such interface is preferably located radially inward of the first flow path 344 so that primarily red blood cells flow through the first flow path 344 during normal conditions. More preferably, the interface between the red blood cells and plasma is disposed at a radial location which is approximate to the edge 350. Such radial location allows the red blood cells to be collected from one side of the interface into the third exit flow path 332 but allows substantially little or no flow of plasma from the other side of the interface into the third exit flow path 332. Plasma and red blood cells primarily flow through the first and third exit flow paths 328 and 332, respectively. The second flow path 330 preferably contains plasma or platelet rich plasma radially inward of the interface and red blood cells radially outward of the interface. Some flow of plasma or red blood cells may occur in the second exit flow path 330, depending on the radial location of the interface, but such flow preferably does not change such location of the interface.
Other flow patterns are possible and may depend on other radial positions of the interface. For example, during an over spill condition, —i.e., where red blood cells flow out of the channel through the first exit flow path 328 with the plasma or platelets—, the interface moves radially inward and the second exit flow path 330 may allow red blood cells to flow from the collection region 346 out of the channel 310. During an under spill condition, —i.e., where plasma or platelets flow out of the channel through the third exit flow path 332 with red blood cells—the interface moves radially outward and the second exit flow path 330 may allow some plasma or platelets from the first exit flow path 328 to flow into the third exit flow path 332.
D. Fourth Embodiment of the Blood Processing Chamber
The inlet 326 is defined by a radially outward portion 309C of the outer side wall portion 308. The edge 323 of the interior wall 322 is radially spaced from the portion 309C and is disposed at a radial location which is approximate to the radial location of the outer side wall portion 308 at a more downstream section of the wall portion 308. Fluid flowing through the inlet 326 follows a path along the interior wall 322 to a location which is radially outward of the edge 323 and then enters the channel 310 through the opening 325.
E. Fifth Embodiment of the Blood Processing Chamber
As compared to the embodiment of
Also as compared to the embodiment of
F. Sixth Embodiment of the Blood Processing Chamber
An inlet 379 is defined between opposing interior radial walls 377 and 381. One of the interior walls 377 joins the outer (high-g) wall portion and separates the upstream and downstream ends of the channel 378. Similar to the embodiment of
A second flow path, generally indicated at 388, also communicates between the upstream and downstream sides 382 and 384 of the barrier 380. As shown in
The chamber 370 further includes first and second exit flow paths 390 and 392, respectively, which are defined by opposing surfaces of interior radial walls. The first exit flow path 390 is located upstream of the barrier 380. The second exit flow path 392 is located downstream of the barrier 380. Both first and second exit flow paths 390 and 392 extend radially inward from the channel 378. The first exit flow path 390 extends radially inward from an opening 391 which is preferably located at the inner side wall portion 372. The second exit flow path 392 extends radially inward from an opening 396. Such opening 396 communicates with a collection region 394, which region is located downstream of the barrier 380 and extends to the interior radial wall 377. Preferably, the first exit flow path 390 is disposed at approximately a 45 degree angle from the second exit flow path 392, although other angles and orientations are also possible.
G. Seventh Embodiment of the Blood Processing Chamber
Above the intermediate end wall portion 460, the inner and outer radial edges of the barrier 426 are not joined so as to allow flow around the barrier 426. As shown in
As shown in
The opening 448 to the first exit flow path 446 as previously described, is defined between the inner edge 432 of the barrier 426 and the inner side wall portion 412. Such opening 448 is defined in part by the barrier 426 and thus, is not located upstream of the barrier. A second exit flow path 450 is located further downstream of the first exit flow path 446 and also lacks any openings upstream of the barrier 426. Openings 451 and 453 of the second exit flow path 450 generally allow communication between the first and third exit flow paths 446 and 454 and such openings 451 and 453 are located downstream of the barrier 426. As previously discussed, plasma may flow from the first exit flow path 446 into the second exit flow path 450 depending on the radial location of the interface. A third exit flow path 454 is located downstream of the first and second flow paths 450 and 452 and includes opening 456 which preferably allows removal of red blood cells from the channel 418. The first flow path 440 allows communication between the upstream and downstream sides of the barrier 426 but also does not allow fluid to exit the channel 418 upstream of the barrier 426. Thus, the channel 418 lacks any opening to remove fluid from the channel upstream of the barrier 418.
The channel 418 further includes a collection region 458 (shown in broken lines in
Plasma or platelet rich plasma is collected radially inward of the interface between plasma and red blood cells. Such plasma is preferably is permitted to flow through the opening 448 into the first exit flow path 446 and out of the channel 418. Radially outward of the interface, red blood cells are permitted to flow through the first flow path 440 into the collection region 458 and exit through the third exit flow path 454. The second exit flow path 450 may contain either plasma or red blood cells, or both, depending on the location of the interface between the plasma and red blood cells. During normal conditions, the interface is preferably maintained between the radial locations of the outer edge 443 and the inner edge 432 of the barrier 426. For such condition, the second exit flow path 450 may primarily allow flow of plasma above such location of the interface although other flow patterns are possible.
H. Eighth Embodiment of the Blood Processing Chamber
As with the embodiment of
Similar to the embodiment of
At a radially inward location shown in
As best seen in
I. Ninth Embodiment of the Blood Processing Chamber
As previously described, a first flow path 440B and a passageway 448A allow communication between the upstream and downstream sides of the barrier 426B. A first flow path 440B is defined in an axial direction between an outer radial edge 434B of a barrier 426B and the outer side wall portion 414B and extends in a radial direction from the top end wall (not shown) of the channel 418B to an intermediate end wall portion 460B. An opening or passageway 448B is defined in a radial direction between the inner side wall portion 412B and the inner radial edge 432B of the barrier 426B and is defined in an axial direction between the top of the channel to the intermediate end wall portion 460B. Below the intermediate end wall portion 460B, the barrier 426B extends fully across the radial extent of the channel 418B to join the inner and outer side wall portions 412B and 414B all the way to the bottom of the channel.
As shown in
J. Tenth Embodiment of the Blood Processing Chamber
Two radially directed interior radial walls 510 and 512 define an inlet, generally at 514, which extends outward from a hub 501. As best shown in
As with previous embodiments, the channel 508 in
As best seen in
As shown in
Any of the above described embodiments may be utilized to perform various biological fluid collection procedures such as a plasma collection procedure, a double-red cell collection procedure, and a platelet collection procedure as well as other collection procedures. Such procedure may be conducted with the blood flow set 12 together with the device 14 and controller 16 previously described. The blood separation chamber in
Although several platelet collection procedures will be described below, it is understood that the above described embodiments may be used for other collection procedures and may employ more than one collection procedure. By way of example and not limitation, typical plasma and double-red collection procedures have been described in at least one of the above-identified patents or applications which have been incorporated by reference herein. In addition, any of the embodiments described herein may be employed to collect more than one blood component in quantities permitted by the relevant country. Although collection of platelet rich concentrate will be discussed in detail below, it is contemplated that any of these methods in its broadest interpretation may include other biological fluid components as well as other blood components.
A. Recirculating for Platelet Collection
Within the chamber 18, separation of the fluid components occurs based on density as in
After sufficient time has passed to allow the interface to form, fluid may be collected separately from either side of the interface—or both sides thereof—through the respective outlet tube 104 or 106 depending on the requirements of the procedure. For example, some platelet poor plasma PPP may be collected radially inward of the interface through the outlet tube 106 and into the plasma collection container 160. Some red blood cells RBC may be collected radially outward of the interface through the outlet tube 104 and flow into the red blood cell collection container 162. The afore-described barriers in the above chambers preferably allow accumulation of platelets which are contained in the buffy coat during such plasma or red cell collection, but platelet collection is not yet initiated.
Prior to collecting the platelets, it is preferred that an under spill condition is imposed upon the fluid components. The under spill condition is shown in
Once a desired hematocrit level is achieved, the fluid in the chamber 18 is preferably kept within the desired hematocrit range. For example, the flow of plasma may be stopped to prevent flow to plasma collection container 160 and the flow of red blood cells from the chamber 18 may also be stopped. Such flow may be stopped by operation of the valve station 30 and/or stopping one or more pumps such as the plasma pump PP. The in-process pump IPP may continue to operate although it is preferably operated at a lower flow rate.
The method further includes the recombination of the separated fluid components within the chamber 18. Recombination is preferably performed by rotation of the chamber in both clockwise and counterclockwise directions. Preferably, the chamber 18 is rotated alternately in clockwise and counterclockwise directions one or more times. The step of recombining preferably results in a uniform blood mixture which includes plasma, red blood cells, platelets and white blood cells having an approximate chamber hematocrit as previously described. The step of recombining preferably lasts approximately one to three minutes, although this time period may vary. The rotation of the chamber in either direction is preferably at a rate preferably greatly reduced than the rate of rotation during initial separation of the components and may be, for example, in the range of approximately 300 to 600 RPM, although other rates of rotation are possible. It is noted that the angular velocities used herein conventionally are two omega although one omega may also be used as well as some combination thereof.
After a sufficient recombination period, the rotor is then restarted to rotate the chamber in a uniform direction so that the flow within the chamber is generally directed from the inlet tube 102 to the outlet tubes 104 and 106. Although the specific speed of the rotor may vary, such speed may be 2500 RPM. The interface between the plasma and red blood cells is allowed to reform. Preferably, collection of the plasma and red blood cells from the chamber 18 is not initiated until the interface is allowed sufficient time to reform.
After the interface has reformed, the plasma and in-process pumps are operated to draw off plasma from the radially inward side of the interface through the outlet tube 106 and red blood cells are drawn from the radially outward side of the interface through flow line 104. As shown in
During recirculation, the preferred pump flow rate ratio of the in-process pump IPP and plasma pump PP is 60/40, although other pump rates may be used depending on the particular conditions of the system. Recirculation may also allow an increasing concentration of white blood cells to settle to the interface between the platelet rich plasma and the red blood cells. Such pump ratio has also been found to have a direct influence on the number of white blood cells WBC that contaminate the platelet rich plasma PRP and the overall platelet concentration collection efficiency. By way of example and not limitation,
Recirculation of the platelet rich plasma PRP may continue for several minutes, preferably approximately two to four minutes although this range may very depending upon the particular procedure. After a sufficient recirculation period, the platelet rich plasma PRP is collected through the outlet tube 106 into the platelet concentrate PC container 161 as shown in
Various modifications to the above-described method are possible. One modification includes operating the in-process pump IPP between at least two different pumping rates to effect recombination of the blood components. For example, fluid may be pumped into the chamber 18 by the in-process pump IPP at a first flow rate while being rotated in a clockwise or counterclockwise direction, and then the rotation in either direction is repeated at a second flow rate. The centrifugal force may be decreased, such as by decreasing the rotor speed, where more than one flow rate is used.
Another modification to includes operating the plasma pump PP during recombination. Plasma is collected through the outlet tube 106 and flows into the in-process container 158. Simultaneously, the flow at the inlet tube 102 is reversed using the in-process pump IPP so that fluid from the chamber 18 also flows into the in-process container 158 through the inlet tube 102. The fluid in the in-process container 158 is then allowed to flow back into the chamber 18 through the inlet tube 102. Therefore, the fluid components are mixed together outside of the chamber 18 and then re-enter the chamber.
It is further possible to modify the pump ratio between the in-process IPP and plasma pumps PP during the collection phase to different ratios at different times during the procedure. Another further modification to the method discussed above includes using a platelet additive solution to replace volume within the chamber 18 after the platelet rich plasma PRP has been collected.
In addition, the length of time of recirculation into and out of the chamber 18 may be modified. For example, lengthening the recirculation period may allow more white blood cells to be forced radially outward to the interface so that the collected platelet rich plasma PRP has a lower white blood cell count. By way of example and not limitation,
B. Decreasing the Centrifugal Force for Platelet Collection
Another method of platelet collection includes decreasing the centrifugal force in order to separate and collect a desired fluid from the chamber. Such fluid is preferably platelet rich plasma PRP which provides a combination of platelets and plasma having a high platelet concentration.
Similar to the previously described method of
After initial separation, the centrifugal force is decreased. Such decrease in force is preferably performed by decreasing the rotational speed of the chamber. The decrease in centrifugal force is preferably sufficient to cause expansion of the platelet layer which resides in the interface, thereby also causing expansion of the interface, as shown in
Upon thickening of the interface, it is desired to collect as many platelets as possible from the interface or buffy coat, as platelet rich plasma PRP. By way of example and not limitation, collection may be performed by moving the expanded interface radially inward toward the inner side wall portion or low-G wall to create an over spill condition, similar to that shown in
Modifications to this method are also possible and such modifications are not limited by the specific structures shown and described herein. In addition, this method may be combined with any of the other methods described herein. Removal of platelets may be performed two or more times during the collection procedure. It is also possible to perform other collection procedures in combination with this method such as separate collection of platelet poor plasma and/or red blood cells.
C. Repeatedly Forming the Interface for Platelet Collection
This method provides for collection of a fluid from one side of the interface and then allows the interface to reform preferably to perform another collection of such fluid. Similar to previous methods discussed above, this method preferably introduces whole blood into the chamber and separates the blood into components based on density, as shown in
Collection of the platelets within the interface is performed by forcing an over spill condition whereby the interface is forced radially upward to the inner side wall portion or low-G wall, as shown in
After a predetermined collection time period, collection is stopped and the interface is allowed to return to its previous intermediate radial location, as shown in
In one modification, the step of removing platelet rich plasma may be repeated at least two times and the interface may be allowed to reform between each successive removal event. In a further modification, this method may be combined with any of the other methods discussed herein. By way of example and not limitation this method may be combined with decreasing the centrifugal force as described above. This method may also be combined with separate platelet poor plasma and/or red blood cell collection.
Any of the previously described chambers may be further utilized to perform a combined red blood cell and plasma collection procedure—which collects red blood cells and plasma separately—instead or in addition to the collection of platelet concentrate collection procedures described above. As such, the system and its components may be modified, as necessary, to perform the steps of this procedure, as described in more detail below.
A. First Draw Cycle
As shown in
After the blood source BS is connected to the device, whole blood WB preferably travels through the appropriate flow tubes as directed by the system to fill the chamber 18. The chamber 18 presumably has been prepared for blood processing through one or more pre-collection procedures such as purging the chamber of air and priming the chamber with saline and/or other procedures as appropriate. The whole blood enters the chamber 18 through inlet flow line 102 until the chamber 18 is full. Whole blood is also drawn from the blood source BS and is temporarily stored in the in-process container 158 for subsequent processing by the chamber 18. The volume of whole blood which is drawn from the blood source BS is measured such as by the weigh scales 62 (
Similar to previous methods discussed above, the whole blood within the chamber 18 is processed to allow separation into its components based on density, as shown in
The first and second fluid components, preferably plasma and red blood cells, are removed from the chamber into their respective collection containers 160 and 162. The volume of each fluid component collected within the containers 160 and 162 is also measured throughout the collection cycle. Processing and collection of the components from the chamber 18 preferably continues until the volume within at least one of the fluid collection containers 160 and 162 reaches a predetermined minimum threshold, but before a targeted total volume of at least one fluid component is collected. When one of the volumes of the containers 160 and 162 reaches the predetermined minimum threshold, the device is configured to allow a full or partial return of at least one of the blood components.
B. Return Cycle
After the desired volume of at least one of the fluid components has been returned to the blood source, the return cycle terminates. Additional return cycles are preferably not commenced, as these would increase the time during which the blood source must be connected to the separation device.
C. Second Draw Cycle
After the return cycle, additional whole blood is withdrawn from the blood source and processed, as previously described and shown in
In the example of
D. Processing Cycle after Disconnection
The blood source BS or donor may be disconnected from the device after the predicted volume of whole blood has been withdrawn. Processing of the whole blood is repeated as described above in
By way of example and not limitation,
Preferably, at least two components such as plasma and red blood cells are removed and stored in their respective collection containers 160 and 162, either until the total targeted volume of at least one blood component is reached or until all the blood has been processed. Further processing or separation may be employed in accordance with any of the above described methods or other collection procedures. For example, any one or more of the above methods may be employed to collect platelet concentrate. Platelet poor plasma may be used to resuspend platelets from the interface in accordance with any of the previously described methods. Alternatively, a platelet additive solution or PAS may be used for collecting platelet concentrate methods. Thus, this method may also be combined with any of the above-described to collect at least two blood components, plasma and red blood cells, as well as platelet concentrate. The amount of collection will vary depending on collection limitations set by the particular country.
As can be seen from the above description, the present invention has several different aspects and features, which are not limited to the specific chamber shown in the attached drawings or to the specific procedures discussed. Variations of these features may be embodied in other structures for carrying out other procedures for blood separation, processing or collection.
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|U.S. Classification||210/512.1, 210/782, 494/37, 210/789, 494/45, 494/56, 210/787, 494/67, 494/43|
|International Classification||B01D21/26, B04B7/10, B04B1/12, B04B3/00, B01D45/12, B04B1/06, B04B5/04, A61M1/36, A61M1/38|
|Cooperative Classification||A61M2205/128, B04B5/0442, A61M1/3696, A61M1/38, A61M1/3693, B04B2005/045|
|European Classification||A61M1/36Z, B04B5/04C|
|12 May 2009||AS||Assignment|
Owner name: FENWAL, INC., ILLINOIS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:MIN, KYUNGYOON;BROWN, RICHARD I;AKONUR, ALP;AND OTHERS;REEL/FRAME:022669/0339;SIGNING DATES FROM 20090330 TO 20090505
Owner name: FENWAL, INC., ILLINOIS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:MIN, KYUNGYOON;BROWN, RICHARD I;AKONUR, ALP;AND OTHERS;SIGNING DATES FROM 20090330 TO 20090505;REEL/FRAME:022669/0339
|6 Oct 2014||FPAY||Fee payment|
Year of fee payment: 4